BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 2965250 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01791
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 19, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WASR ECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS RISING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPEDANCE HAS BEEN RISING ON THE RIGHT VENTRICULAR (RV) LEAD. IT WAS NOTED THERE WAS A POSSIBLE LEAD FRACTURE. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68398 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5034

    Patients

    Seq Age Sex Outcome Treatment
    1 00093 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR